XTRA BOWL SET X/225Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033178110044), received between Mar 4, 2022 and Mar 4, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Chemical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2022Chemical Problem; Chemical Problem

  SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, ON (B)(6) 2022, DURING AN EMERGENCY PROCEDURE, SUDDEN HYPOTENSION OCCURRED. MEDICAL TEAM ADMINISTER BLOOD COLLECTED FROM THE CELL SAVER TO THE PATIENT. ACCORDING TO INFORMATION, DURING THE ADMINISTRATION, BLOOD WAS DARK COLOR AND ADMINISTRATION WAS INTERRUPTED. AT THIS TIME, PATIENT SHOWED BRADYCARDIA AND MEDICAL TEAM ELECTED TO ADMINISTER ATROPINE TO THE PATIENT AND TO PERFORM BLOOD GASES ANALYSIS. BLOOD GASES ANALYSIS SHOWED HIGH SERUM POTASSIUM (6.7 MMOL/L) THAT MEDICAL TEAM ELECTED TO TREAT BY INJECTION OF CALCIUM CHLORIDE AND INSULIN/GLUCOSE, CONTROL AT 4 MMOL/L. THE MEDICAL TEAM SENT TO ANALYSIS THE DARK BLOOD AND HIGH POTASSIUM (22.5 MMOL/L) AND SODIUM (14 MMOL/L) WERE FOUND. ACCORDING TO CUSTOMER, HYPERKALEMIA ON POTENTIAL HEMOLYSIS OF THE CONTENT OF CELL SAVER HAS OCCURRED. THE PATIENT HAS BEEN TRANSFERRED TO RESUSCITATION/INTENSIVE CARE FOR MONITORING AND IS NOW STABLE. DISPOSABLE DEVICE HAS BEEN SAVED BY THE CUSTOMER.

  Patient problems: Bradycardia; Hemolysis

  MAUDE report 13665461 ↗